Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Degarelix.

Patients without evidence of metastatic disease, with tissue remaining from a pre-treatment biopsy, and who are being considered for standard treatment by prostatectomy, will be invited to participate and will be on study for up to 15 months.

It had five arms (groups): Arm 1: Degarelix (active comparator), Arm 2: Degarelix and pTVG-AR (experimental), Arm 3: Degarelix and pTVG-AR and Nivolumab (experimental), Arm 4: Degarelix and pTVG-AR and Cemiplimab (experimental) and Arm 5: Degarelix and pTVG-AR and Cemiplimab and Fianlimab (experimental).

The registry classes the interventions as biological and drug.

More on the Plan

All participants will receive treatment with degarelix for 8 weeks prior to prostatectomy.

In the first part of the study encompassing the first 3 treatment arms, participants will be also be randomized to receive either no additional treatment, a DNA vaccine encoding AR, or a DNA vaccine encoding AR and nivolumab.

The additional arms will randomize patients to receive cemiplimab (PD-1 antagonist) with vaccine or cemiplimab with fianlimab (LAG-3 antagonist) and vaccine, with each agent initiated with the first immunization.

Participants receiving vaccination will begin that treatment prior to degarelix, based on preclinical findings that this may be a preferred sequence of treatment.

Who Took Part

The registry lists 57 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically confirmed adenocarcinoma of the prostate. Patients must be considered candidates for prostatectomy as per standard of care. High-risk patients for recurrent disease, with high risk defined based on one of the following criteria:. Gleason score 7 and baseline serum prostate specific antigen (PSA) \> 20 ng/mL. Gleason score \> 7.

The full record lists 20 inclusion and 24 exclusion criteria; among the exclusions: prior radiation to the prostate; treatment with any of the following medications while on study is prohibited, washout period not required except as indicated:; major surgery within 4 weeks of registration is prohibited.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Degarelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Degarelix study: the participants and staff both knew the treatment.

It started in 2021-12-16 with completion listed for 2026-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pathological Complete Response Rate (pCR) (time frame: at prostatectomy (up to 3 months)). Minimal Residual Disease (MRD) Rate (time frame: at prostatectomy (up to 3 months)). Incidence of Adverse Events (time frame: up to 15 months).

It also tracked 3 secondary outcomes, for example Progression-Free Survival (PSA) at 1-year and Median Progression-Free Survival.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Degarelix in 57 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Degarelix compound page, all human trials.